Model-assisted process development for preparative chromatography applications

BioProcess International

Volumn 9, Issue 3, 2011, Pages 48-56

  Westerberg, Karin ^a   Hansen, Ernst Broberg ^b   Hansen, Thomas Budde ^b   Degerman, Marcus ^b   Nilsson, Bernt ^a  

^a LUND UNIVERSITY   (Sweden)

^b NOVO NORDISK A S   (Denmark)

Author keywords

Design space; Process modeling; Process variation; QBD

Indexed keywords

ADSORPTION KINETICS; CALIBRATION; CHROMATOGRAPHY; DRUG DESIGN; DRUG IMPURITY; DRUG MANUFACTURE; DRUG QUALITY; FOOD AND DRUG ADMINISTRATION; ION EXCHANGE CHROMATOGRAPHY; PH; PROCESS DEVELOPMENT; PRODUCT SAFETY; QUALITY BY DESIGN; RISK ASSESSMENT; SHORT SURVEY;

EID: 79952646854     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (8)

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2. ICH, Draft Consensus Guideline: Pharmaceutical Development Annex to Q8. November 2008; http://private.ich.org/cache/compo/363-272-1.html.
3. ICH, Q9: Harmonized Tripartite Guideline: Quality Risk Management. November 2005; http://private.ich.org/cache/compo/363-272-1.html.
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